A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982163
• Other study ID #: 08-003-26
• Status: Completed
• Phase: N/A
• First received: September 22, 2009
• Last updated: September 22, 2009
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.

Description:

Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must:

1. be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;

2. be at least 18 years of age;

3. be willing to avoid disallowed medication, such as anti-allergy therapies

4. have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;

5. have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;

Exclusion Criteria:

• Subjects may not:

1. have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);

2. have had any ocular infection within the last 30 days;

3. have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);

4. wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Locations

Country	Name	City	State
United States	ORA, Inc.	North Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diary Data		4 weeks	No